We propose a new Tactile Breast Imager (TBI) for early breast cancer detection intended for effective low-cost mass pre-screening. The device will build on developments made in the field of mechanical imaging (MI), a method that translates the tissue's elastic properties into a digital 3-D map of the tissue in the region of interest. It enables not only a superior method for clinical use, but also a powerful new paradigm of screening in which the patient collects data at home and efficiently transfers it to her physician for review. As is shown in this proposal, the underlying technology has been demonstrated to yield images of subcutaneous lesions that are well below the threshold of detectability by manual palpation. The proposed effort under this grant is to demonstrate that this technology may be incorporated into an easy to use form and determine the requisite skill and training requirements for robust data collection. The key developments necessary to achieve this goal lie in two categories: First is the development of the examination procedure and modification of equipment functionality to simplify the examination process. The ability to acquire sufficiently accurate data in a reliable manner depends largely on three aspects: the procedure in which the data is collected, the design of the equipment to facilitate this process, and subsequent processing of the data to minimize the effects of procedural and anatomical/physiological variations. While the majority of the necessary elements have already been developed to an adequately functional level, they are generally large and cumbersome and so would impede the ease of use of the TBI. The miniaturization and productization of the TBI probe and refinement of the data processing/transfer components is necessary. We aim to implement these developments in a prototype TBI and evaluate the resulting sensitivity for lesion detection a effectiveness and ease of use for both the clinical and home-use applications. Under Phase I grant we aim to develop an optical examination procedure, a suitable user/TBI interface design, and robust post procedure data processing algorithms to allow reliable and sensitive data to be obtained with minimal training. PROPOSED COMMERCIAL APPLICATIONS: The proposed TBI is an easy-to-use diagnostic tool that has the potential to effectively replace breast self-examination by health care professionals. The potential result is a significant decrease of the size of breast cancers at detection and consequently, more effective treatment, decrease in patient morbidity and mortality, and reduced health care costs. The potential gross revenues on the sale of this device is $520,000,000.